Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasophar… (NCT07136519) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Toripalimab, Induction Chemotherapy, Radiation Therapy With Omega-3 for Locally Advanced Nasopharyngeal Carcinoma
30 participantsStarted 2025-08-22
Plain-language summary
The aim of this study is to evaluate the efficacy, adverse reactions, nutritional status analysis, and quality of life analysis of Toripalimab Plus Induction Chemotherapy Followed by Radiation Therapy Combined with Omega-3 in the treatment of locally advanced nasopharyngeal carcinoma.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Written informed consent can be provided, and understanding and compliance with research requirements and evaluation schedules are required.
* On the date of signing the informed consent form, the age range is between 18 and 65 years old (or the legal age specified by local laws).
* Pathological diagnosis is non keratinizing carcinoma of the nasopharynx (differentiated or undifferentiated, i.e. WHO classification II or III).
* Clinical staging is anyTN2-3M0 or T4N1M0 (AJCC8th/UICC staging).
* ECOG score is 0-1 points.
* Hemoglobin (HGB) ≥ 90g/L, white blood cell (WBC) ≥ 4.0 × 109/L, platelet (PLT) ≥ 100 × 109/L.
* Liver function: ALT and AST\<2.5 times the upper limit of normal (ULN), total bilirubin\<2.0 × UL, serum albumin ≥ 28g/L.
* Renal function: Serum creatinine\<1.5 × ULN or creatinine clearance rate (CrCl) calculated value ≥ 60mL/min (Cockcroft Gault formula).
* Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group).
* The international normalized ratio (INR) and activated partial thromboplastin time (APTT) are ≤ 1.5 × ULN (unless the subject is receiving anticoagulant treatment and the coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant treatment at the time of screening).
Exclusion Criteria:
* Nasopharyngeal cancer patients with recurrence and distant metastasis.
* Pathology shows k…
What they're measuring
1
2-year progression free survival period
Timeframe: From enrollment to the end of treatment at 2 years
Trial details
NCT IDNCT07136519
SponsorAffiliated Hospital of Guangdong Medical University